FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/091168 [Registered on: 18/07/2025] Trial Registered Prospectively
Last Modified On: 16/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Using coronary calcium scores to predict heart disease: Comparing this simple scan with traditional angiograms in people with and without symptoms 
Scientific Title of Study   Assessing coronary calcium score as a non-invasive predictor of coronary artery disease severity: A comparative analysis with angiography in symptomatic and asymptomatic populations 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashwathi A K 
Designation  DrNB Trainee 
Affiliation  Narayana Multispeciality Hospital, Mysore 
Address  CAH/1, 3rd Phase, Devanur 2nd Stage , R.S.Naidu Nagar

Mysore
KARNATAKA
570019
India 
Phone  9791791978  
Fax    
Email  ashwathipradeep@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Keshavamurthy V 
Designation  Cardiology HOD 
Affiliation  Narayana Multispeciality Hospital, Mysore 
Address  CAH/1, 3rd Phase, Devanur 2nd Stage , R.S.Naidu Nagar

Mysore
KARNATAKA
570019
India 
Phone  9791791978  
Fax    
Email  keshava.murthy.dr01@narayanahealth.org  
 
Details of Contact Person
Public Query
 
Name  Ashwathi A K 
Designation  DrNB Trainee 
Affiliation  Narayana Multispeciality Hospital, Mysore 
Address  CAH/1, 3rd Phase, Devanur 2nd Stage , R.S.Naidu Nagar

Mysore
KARNATAKA
570019
India 
Phone  9791791978  
Fax    
Email  ashwathipradeep@gmail.com  
 
Source of Monetary or Material Support  
Narayana Multispeciality Hospital, CAH/1, 3rd Phase, Devanur 2nd Stage , R.S.Naidu Nagar Mysore, Karnataka, India 570019 
 
Primary Sponsor  
Name  Ashwathi A K 
Address  Narayana Multispeciality Hospital, CAH/1, 3rd Phase, Devanur 2nd Stage , R.S.Naidu Nagar Mysore, Karnataka - 570019 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashwathi A K  Narayana Multispeciality Hospital  CAH/1, 3rd Phase, Devanur 2nd Stage , R.S.Naidu Nagar
Mysore
KARNATAKA 
9791791978

ashwathipradeep@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Narayana Health Academic Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Presenting with symptoms of cardiac ischemia or asymptomatic individuals identified as high risk based on cardiovascular risk scores 
 
ExclusionCriteria 
Details  history of coronary revascularisation/ myocardial infarction/severe renal impairment/critically ill patients/pregnancy or lactation 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the reliability of coronary artery calcium score to predict coronary artery disease  To assess the reliability of coronary artery calcium score to predict coronary artery disease 
 
Secondary Outcome  
Outcome  TimePoints 
Compare calcium scores with angiographic findings  Baseline 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Coronary artery disease is a major global health concern, contributing significantly to morbidity and mortality due to the build up of atherosclerotic plaque in the coronary arteries. Although coronary angiography remains the gold standard for diagnosing CAD, its invasive nature and associated risks limit its widespread use. Coronary Artery Calcium scoring, a non-invasive technique utilizing ECG gated CT, provides a safer and more cost effective approach to quantifying calcified plaque and assessing atherosclerotic burden. However, its inability to detect non-calcified plaques and challenges in monitoring disease progression, particularly in patients on statin therapy, underscore the necessity for further investigation. This study seeks to validate CAC scoring as a reliable alternative to coronary angiography, improving CAD diagnosis and management, particularly in underserved populations. By addressing its current limitations and incorporating emerging technologies, CAC scoring has the potential to revolutionize cardiovascular care and enhance patient outcomes.

 
Close